RE:RE:Scope Cleaning is Important but Grossly InadequateWhat I referred to in a previous post was a few suggesting at the AAMI table (discussing the upcoming draft to be discussed again at the annual AAMI sterilization meeting March 20 - 21 where WG 84 will meet) that HLD might be adequate for some endoscopes, including gastroscopes or colonoscopes, depending on their use. The group appeared to reach a consensus that duodenoscopes, ureteroscopes, cystoscopes and bronchoscopes at least should be regarded as so typically used for crtical procedures that enter sterile tissues that these require terminal sterilization. The group was unable, in my opinion, to achieve consensus regarding some scopes and these will continue to require further discussion to make the new standards document draft.
The point of the previous paper I discussed here is that it has been repeatedly shown that gastroscopes are NOT adequately decontaminated with proper cleaning and HLD alone. There is data that continues to show unacceptable levels of bacterial, ATP, and protein contamination of these scopes, and, as they are also very frequently used to perform 'sterile' biopsies or other procedures (including endoscopic stapling or suturing of the stomach, for example) they should be sterile given the inability of HLD to consistently reduce contamination to zero (is any contamination an acceptable level? I don't think so). Part of the point is that there should be no contamination at all for any scope that is being used for a critical procedure. The Spaulding Classification already recommends terminal sterilization for all endoscopes when this is possible. Putting more cost-efficient and practical VP4's into the hospitals and GI clinics across N. America will make this objective possible. It is possible. Today.
The separate question is regarding some interested parties not wanting to sterilize colonoscopes and suggesting that recent better adherence to cleaning procedures has reduced or mitigated the problem of contamination. There are 11-13 Million colonscopies and sigmoidoscopies done annually in the US. Biopsies and polypectomies are done in 25-50% of these cases. The bowel is not a sterile area of course, but to introduce possible outside contaminants or bacteria (such as C. difficile) from another patient is not acceptable. One person voiced their opinion at the committee that the cost of instituting terminal sterilization for colonoscopies was just too expensive to his and other clinics, it would slow down the throughput of patients, (thus resulting in less income to him and others, of course), and it would raise legal liability issues for those who are slow to comply. There is some controversy about the incidence of infection with colonoscopies, with this person repeatedly suggesting a very low incidence from a very flawed and old outdated study with which he was involved. This theory has recently again been disproven with a study of colonoscopies and sigmoidoscopies out of Tiawan in 2017 showing an infection rate of at least .5%. This is not a small number, as you can see, given the number of procedures done annually in the US and N. America. How much lower would the infection rate be if the scopes were terminally sterilized? Not known, as far as I am aware, and difficult to determine.
Bottom line, while some in the industry, particularly busy GI specialists who are concerned more about their own costs, incomes, and reduced numbers of procedures having to use sterile colonoscopes possibly than being concerned for the safety of their patients, the great majority of level heads at AAMI and surely at FDA know that the only way to address the scope contamination problem is terminal sterilization. Instituting recommendations in their new standards in 2019 making terminal sterilization for duodenoscopes, gastroscopes, ureteroscopes, cystoscopes, bronchoscopes will make medical care safer for patients, without a doubt. Demanding colonscopes be sterile, too, is in patients' best interests, though not in the interest of some clinics, doctors, etc..
A resolution to the scope contamination problem will require a joint effort by regulators, TSO3 with their effective and efficient VP4 option, and scope manufacturers to make their scopes more robust and durable with better qualtiy adhesives and lubricants.
TSO3 remains on the forefront of this move to terminal sterilzation for endoscopes. Soon, the FDA should recognize their ability to terminally sterilze duodenscopes, as is already recognized in Europe and Canada. Now, if they only could get their revolutionary product into the market to solve the problems for which TSO3's scientists and management have invented the solution!!
We will see what management has come up with at their Investor Day tomorrow to reduce JNJ's market share not just a bit, but to blow them out of the proverbial water in this market! The VP4 is in a different league from the competition. We just need implementation and installs. Once these get to a critical level, TSO3 will own the low temperature market. Period.